Trospium Chloride

Product NDC: 0591-3636
Requested package NDC: 0591-3636-60
11-digit product format: 005913636
Labeler code: 0591
Product ID: 0591-3636_d9bd46c2-65b5-495b-acae-fcea5f775787
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trospium Chloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA091289
Marketing category: ANDA
Marketing start: 2012-10-12
Substance: TROSPIUM CHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-3636	0591-3636-60	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091289-001	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A091289-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091289-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091289-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091289-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091289-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091289-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091289-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091289-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091289-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091289-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091289-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091289-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091289-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091289-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091289-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091289-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091289-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091289-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091289-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091289-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091289-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091289-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091289-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091289-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091289-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091289-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091289-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091289-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091289-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091289-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091289-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091289-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091289-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091289-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091289-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091289-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091289-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091289-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091289-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091289-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091289-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Trospium Chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TROSPIUM CHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1E6682427E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857564	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8b8d434c-daa2-4bf2-bde6-3e59f81bd88b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bfc41181-d174-476d-8a52-4a385ae9213d	Product name	1	20250423
7c473500-2ad1-88f9-e10e-6f8136eda28c	Product name	4	20250226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9151f483-8353-9cd4-427d-86fb1b5ba7ea	Product name	4	20211027
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-3636-30	Trospium Chloride	30 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	30		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3636-30	EA - Each	0591-3636	372bb3f2-a5bb-4777-ae79-7028091f4cf1	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TROSPIUM CHLORIDE	ACTIVE INGREDIENT	1E6682427E	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
TROSPIUM	ACTIVE MOIETY	T4Y8ORK057	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
ETHYLCELLULOSE (10 MPA.S)	INACTIVE INGREDIENT	3DYK7UYZ62	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)	INACTIVE INGREDIENT	99Q3C7L77T	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
SUCROSE	INACTIVE INGREDIENT	C151H8M554	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	16
TROSPIUM CHLORIDE	ACTIVE INGREDIENT	1E6682427E	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TROSPIUM	ACTIVE MOIETY	T4Y8ORK057	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
ETHYLCELLULOSE (10 MPA.S)	INACTIVE INGREDIENT	3DYK7UYZ62	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)	INACTIVE INGREDIENT	99Q3C7L77T	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3636	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	18	Current NDC, Legacy NDC, 1 package rows	20181129_8b8d434c-daa2-4bf2-bde6-3e59f81bd88b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trospium Chloride	TROSPIUM CHLORIDE	Golden State Medical Supply, Inc.	8e5e2b3a-467b-4312-9778-8ff2ce938838	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091289 application number: ANDA091289
Trospium Chloride	TROSPIUM CHLORIDE	Actavis Pharma, Inc.	8b8d434c-daa2-4bf2-bde6-3e59f81bd88b	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091289 application number: ANDA091289 ndc (product): 0591-3636

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1E6682427E	TROSPIUM CHLORIDE	10405-02-4	TROSPIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857564	trospium chloride 60 MG 24HR Extended Release Oral Capsule	PSN	8b8d434c-daa2-4bf2-bde6-3e59f81bd88b	20
857564	24 HR trospium chloride 60 MG Extended Release Oral Capsule	SCD	8b8d434c-daa2-4bf2-bde6-3e59f81bd88b	20
857564	trospium chloride 60 MG 24 HR Extended Release Oral Capsule	SY	8b8d434c-daa2-4bf2-bde6-3e59f81bd88b	20
857564	trospium chloride 60 MG 24HR Extended Release Oral Capsule	PSN	8e5e2b3a-467b-4312-9778-8ff2ce938838	5
857564	24 HR trospium chloride 60 MG Extended Release Oral Capsule	SCD	8e5e2b3a-467b-4312-9778-8ff2ce938838	5
857564	trospium chloride 60 MG 24 HR Extended Release Oral Capsule	SY	8e5e2b3a-467b-4312-9778-8ff2ce938838	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3636-60	00591363660	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3636-60)	2012-10-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trospium Chloride	Golden State Medical Supply, Inc.	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	5
Trospium Chloride	Actavis Pharma, Inc.	2025-07-30	HUMAN PRESCRIPTION DRUG LABEL	20